Kornimate/medical-research-clean huggingface dataset:
comparison of brugger's exercise with and without kendall exercises in sterno-symphyseal syndrome

Conditions: Upper Crossed Syndrome

Summary: sterno-symphyseal syndrome is a natural result of prolonged sitting work, especially with computers .in actual it is the approximation between pubic symphysis and sternum. the aim of study will be to compare the effects of brugger's exercise with and without kendall exercises on pain, craniovertebral angle and range of motion in patients with sterno-symphyseal syndrome. group a will be treated with kendall exercises and brugger's exercise and group b will receive brugger's exercise only. standard treatment will be provided to both groups. outcome measures will be conducted at baseline, after 3 weeks and by the end of 6 weeks of treatment. data will be analyzed using spss software version 25.

sterno-symphyseal syndrome is a natural result of prolonged sitting work, especially with computers. it is basically the approximation between the sternum and pubic symphysis. this syndrome has been given several names including posterior cervical-dorsal syndrome and more commonly computer back or student syndrome. this posture is associated with increased muscular tension and faulty respiration habit. the aim of study will be to compare the effects of brugger's exercise with and without kendall exercises on pain, craniovertebral angle and range of motion in patients with sterno-symphyseal syndrome. a randomized clinical trial will be conducted at umar hospital lahore through convenience sampling technique on patients which will be allocated using simple random sampling through computer generated method into group a and group b. group a will be treated with kendall exercises and brugger's exercise and group b will receive brugger's exercise only. standard treatment will be provided to both groups. outcome measures will be conducted through pain, craniovertebral angle and neck range of motion at baseline, after 3 weeks and by the end of 6 weeks of treatment. data will be analyzed using spss software version 25. after assessing normality of data by shapiro-wilk test, it will be decided either parametric or non-parametric test will be used within a group or between two groups.

Eligibility criteria:
inclusion criteria: • age group between 18-35 years old * gender: male and female both included (23). * subjects with slumped posture with craniovertebral angle less than 50 degree (12). * subjects having distance from xiphoid process to pubic symphysis less than 28 cm (11 inches). * subjects sitting more than 4 hours a day (12). * subjects with upper back pain with \< 7 score on numeric pain rating scale exclusion criteria: • subjects with untreated fractures on cervical and upper thorax spine. * neoplasm on spine. * cervical disc prolapses. * subject with psychological disorder. * vertebro basilar insufficiency and migraine are excluded (12).

Keywords: craniovertebral anglle. exercise pain posture sterno-symphyseal syndrome
a phase 2a study to assess safety & pharmacokinetics of sustained release sodium nitrite in patients with diabetic pain

Conditions: Diabetes

Summary: in this study, subjects with diabetic neuropathic pain (dnp) will be treated for 12 weeks with either placebo, 40 or 80 mg sustained release sodium nitrite (tv1001sr) twice daily. primary endpoints will be safety and pharmacokinetics. assessment of the study medications affects on pain following treatment will also be recorded.

this is a dose-ranging study to evaluate the safety, pharmacokinetics, and tolerability of multiple doses of an oral, sustained release formulation of sodium nitrite (tv1001sr) in subjects with dnp. the primary objective is to assess the safety and tolerability of multiple doses of twice daily 40 mg and 80 mg tv1001sr compared with placebo over a 12 week treatment period and the pharmacokinetics of the sustained release formulation of sodium nitrite. secondary objectives are to evaluate the pharmacokinetics and markers of functional improvement including pain questionnaires, quantitative sensory testing and changes in markers of diabetes.

Eligibility criteria:
inclusion criteria: * female subjects must be post-menopausal, sterilized or using suitable birth control * diagnosis of diabetes (hba1c \> 6.0) * diagnosis of diabetic peripheral neuropathy pain in feet * presence of ongoing diabetic neuropathic for at least 3 months * a pain score of greater than or equal to 4 on the numerical pain rating scale at screening * ability to provide written informed consent exclusion criteria: * patients with fibromyalgia or regional pain caused by lumbar or cervical compression * history or diagnosis of significant neurological disease * history and diagnosis of clinically significant psychiatric diseases * serious liver disease * poorly controlled diabetes * hypersensitivity to sodium nitrite or related compounds * life expectancy \< 6 months * a chronic illness that may increase the risks associated with this study * active malignancy requiring active anti-neoplastic therapy that will, in the opinion of the investigator, interfere with study treatment or participation * pregnant or nursing women * current diagnosis of alcohol or other substance abuse * current use of sildenafil or other phosphodiesterase type 5 inhibitors * history of methemoglobinemia, (met-hb ≥ 15%) * subject is involved in litigation or receives worker's compensation * inability to speak english

Keywords: neuropathy
implementing proms and prems in routine clinical care: assessment of requirements and impact

Conditions: PROMs; PREMs; Implementation Research; Impact Evaluation

Summary: there has been increasing interest in the use of patient-reported outcomes and experience measures (proms and prems) in clinical practice; yet few empirical studies have been conducted to evaluate the usefulness of such implementation. objective: to evaluate the efficacy of the implementation of proms and prems in routine clinical care for improving health outcomes and satisfaction with health management. design: randomized control trial. setting: in and outpatient departments of a public hospital in spain. participants: 1,440 adult patients managed for breast cancer, prostate cancer, chronic kidney disease, or bariatric surgery. intervention: patients will monthly complete, through an app from their smartphones, proms and prems (arm a, n=480), or only prems (arm b, n=480). responses to proms will be transformed into a graphic summary, accessible for physicians and patients at the follow-up visits of the project (9 and 18 months after recruitment). main outcome measures: comparison of change among arms on the assessment variables - such as health-related quality of life (eq-5d-5l), satisfaction with care, or patient-professionals communication. these constructs will be measured at recruitment and at follow up visits for all patients, regardless of their arm allocation (arm c would only be administered these questionnaires, without intervention, n=480). expected results: incorporating proms and prems in routine clinical care may improve patients\&#39; and health professionals\&#39; experiences on health care, as well as improve patients\&#39; health.


Eligibility criteria:
inclusion criteria: * being an active patient of the nephrology service, prostate cancer service, breast cancer service, or bariatric surgery service * in possession of an email account and having basic knowledge of how to manage emails * in possession of a smartphone, computer, or tablet with access to the internet * fluent and able to read in spanish exclusion criteria: - under 18 years of age

Keywords: prms implementation implementation research implementation evaluation proms prems impact evaluation rct health services research
device assisted full thickness resection versus endoscopic submucosal dissection for duodenal neuroendocrine tumors

Conditions: Neuroendocrine Tumors

Summary: introduction : the incidence of duodenal neuroendocrine tumors (dnets) is increasing. endoscopic resection is recommended for the management of small dnets measuring ≤10 mm. various endoscopic techniques have been utilized for the resection of dnets including endoscopic mucosal resection (emr), band ligation assisted emr, endoscopic submucosal dissection (esd). however, the published studies report a high rate of histologically incomplete resection even with esd. more recently, device assisted endoscopic full thickness resection (eftr) has emerged as a safe and effective resection modality in cases with upper and lower gastrointestinal (gi) mucosal as well as submucosal lesions. there is limited data on the outcomes of eftr in cases with dnets. in this study, we aim to compare the rate of histologically complete resection (r0) with esd and eftr in cases with dnets.

primary objective: rate of r0 resection in both the groups secondary outcomes: 1. technical success: defined as en-bloc resection of the lesion without any residual lesion endoscopically 2. procedure duration 3. adverse events inclusion criteria: 1. adult patients (≥18 years) with biopsy proven duodenal neuroendocrine tumors (dnets) 2. size of the lesion \<15 mm 3. absence of local and distant metastases (eus and dotanoc scan) 4. willing to provide informed consent exclusion criteria: 1. large lesions \>15 mm 2. invasion of muscularis layer and beyond on imaging (eus) 3. scarring or deformity in duodenum 4. active duodenal ulcer 5. history of prior resection 6. coagulopathy

Eligibility criteria:
inclusion criteria: 1. adult patients (≥18 years) with biopsy proven duodenal neuroendocrine tumors (dnets) 2. size of the lesion \<15 mm 3. absence of local and distant metastases (eus and dotanoc scan) 4. willing to provide informed consent exclusion criteria: 1. large lesions \>15 mm 2. invasion of muscularis layer and beyond on imaging (eus) 3. scarring or deformity in duodenum 4. active duodenal ulcer 5. history of prior resection 6. coagulopathy
positive feeding of the preterm infant

Conditions: Preterm Infant; Breast Feeding; Bottle Feeding; Enteral Feeding; Cue Based Feeding; Develomentally Supportive Care

Summary: the goal of this feasibility study is to assess the feasibility to implement a feeding strategy for preterm infants. the main questions it aims to answer are: * is it feasible to implement the pop-intervention in a level 3a category neonatal intensive care unit? * is the pop-intervention acceptable for parents of preterm infants and health care personnel working in neonatal intensive care unit? parents of preterm infants and health care personnel will be asked to follow a protocol of a feeding strategy based on the preterm infants development and cues throughout the nicu-stay.

the parents will be recruited before or as soon as possible after birth. the intervention will start as soon as the parents have given written consent for themselves and behalf of their infant. the intervention is developed in line with the mrc framework of developing and evaluating complex interventions in an iterative and dynamic way. the intervention will be based on parents counseling and an infant feeding protocol.

Eligibility criteria:
inclusion criteria: * gestational age of 28 weeks * post menstrual age of 28 weeks after transition from regional hospital exclusion criteria: * diagnoses or malformations that makes eating difficult * triplets or more * parents not speaking/understanding norwegian or english * parents with challenges or special needs for follow up
efficacy and safety of a double icodextrin dose in elderly incident capd patients on incremental pd.

Conditions: Renal Insufficiency

Summary: the dido study is an open-label, randomised, multicentre study with 2 parallel groups in incident capd patients aged of 65 at minimum : * one group in which patients will receive 2 bags of icodextrin/day and 1 bag of glucose * one group in which patients will receive 1 bag of icodextrin/day and 2 bags of glucose.

the dido study evaluates efficacy and safety of a double icodextrin dose in elderly incident capd patients on incremental peritoneal dialysis therapy. the objective is to demonstrate the superiority and safety of using 2, as compared to 1, icodextrin bags / day, in a cohort of elderly incident continuous ambulatory peritoneal dialysis (capd) patients using incremental peritoneal dialysis (pd) (3 bags / day), with the aim of prolonging the period of time for which incremental pd can be used. this is a phase iv open-label, randomised, multicentre study with 2 parallel groups, which will take place in up to 30 hospital out-patient clinics un europe. it is planned to include 160 patients on the run-in period in order to obtain 100 randomised patients and 90 patients evaluable at the primary endpoint (45 in each group). the duration of patient recruitment is estimated at 1 year but this may be extended until all 160 patients are recruited. there are 2 periods: a run-in period of 2 months and a treatment period of 18 months.

Eligibility criteria:
inclusion criteria: run-in period * incident capd patients who require incremental pd and in whom a 1.5l dialysate can be safely instilled, * creatinine clearance \< 20 ml / min (calculated with the modification of the diet in renal disease \[mdrd\] formula), * age ≥ 60 years, * patients willing and able to give written informed consent and comply with the requirements of the study protocol. treatment period * patients having successfully completed the run-in period (achieving euvolemia) exclusion criteria: run-in period * contraindication for capd according to local practice, * life expectancy \< 6 months, * known allergy to icodextrin (cloudy dialysate or skin rash), * need for amino-acid prescription, * treatment with any investigational product within 30 days prior to signature of the informed consent form (icf) * history of drug or alcohol abuse within 3 months prior to the signature of the icf. treatment period * severe symptomatic arterial hypotension at the end the run-in period in the investigator's opinion, * excessive ultrafiltration (uf) during the run-in period, * allergy to icodextrin discovered during the run-in period, * impossibility to achieve adequate pd regimen within the run-in period (catheter dysfunction, peritoneal leaks, inadequate compliance, psychosocial reasons)

Keywords: icodextrin double dose elderly incident capd patients dido study
trial evaluating postop pain and muscle strength among regional anesthesia techniques for ambulatory acl reconstruction

Conditions: Rupture of Anterior Cruciate Ligament; Tear of Anterior Cruciate Ligament

Summary: despite the apparent multifaceted benefit in differentiating blockade sites and duration of nerve blockade, the efficacy of continuous adductor canal blockade utilized specifically in acl reconstruction has not been extensively studied. this study will test the hypothesis that the use of the adductor canal continuous nerve catheter will result in lower subjective pain scores on postoperative day 2 and improved quadriceps strength on postoperative day 1.

study participants will be randomized to 2 groups: (1) continuous adductor canal nerve catheter or (2) long-acting single bolus adductor canal nerve block. following random selection via random envelope selection patients will receive the following procedures. both groups will receive ultrasound guided femoral nerve block with 20cc of 2% mepivacaine \<20 minutes prior to in room time. intraoperative care will consist of general anesthesia under the care of the attending anesthesiologist assigned to the patient. induction will include a propofol bolus and placement of laryngeal mask airway. intraoperative opioid should be limited to no more than 150mcg of fentanyl. upon completion of wound closure, appropriate dressing placement, emergence from anesthesia and removal of lma, patients to be taken to pacu. once adequately awake and alert, group 1 patients 1 will receive ultrasound guided adductor canal continuous nerve catheter using normal saline as bolus for placement, followed by initiation of 1/8% bupivacaine infusion through catheter at 8cc/h. group 2 will receive ultrasound guided adductor canal nerve block with 10cc of 0.5% ropivacaine + 2mg dexamethasone (0. 5cc), keeping total injectate at 10.5cc to spare significant proximal spread to femoral nerve14. after adequate instruction including catheter education (if applicable) patients are to be discharged home.

Eligibility criteria:
inclusion criteria: * age 14 and older * patients who are scheduled to undergo an acl reconstruction with patella or allograft * patient does not have a contraindication to receiving regional anesthesia exclusion criteria: * allergy to local anesthetics, dexamethasone, or adhesive tape * patients undergoing hamstring graft for acl * preexisting infection at site of needle insertion * immunocompromised patients * preexisting sensory or motor deficit in operative extremity * patient on chronic opioid treatment. * patient having a revision of previous acl reconstruction. * pregnancy and lactating women
benefit of hypothermia in ohca complicating ami

Conditions: Out-Of-Hospital Cardiac Arrest; Myocardial Infarction, Acute; Hypothermia Neonatal

Summary: to determine the clinical effectiveness of hypothermia treatment in patients with out-of-hospital cardiac arrest complicating acute myocardial infarction.

out-of-hospital cardiac arrest (ohca) is a leading cause of mortality worldwide. due to significant improvement in the management of patients with ohca, an increasing number of initially resuscitated patients are being admitted to hospitals. nevertheless, ohca remains associated with a poor prognosis, with a survival rate of approximately 8.8% to hospital discharge. moreover, international registry data have indicated that favorable neurological outcome at hospital discharge or 30 days after ohca is only 2.8-18.2% across all registries. the majority of adult cardiac arrest cases are associated with obstructive coronary artery disease. thus, current guideline recommended that immediate angiography and primary revascularization in all patients with resuscitated cardiac arrest and st-segment elevation on electrocardiography, and also in patients with resuscitated cardiac arrest without st-segment elevation, but with high probability of acute coronary occlusion. however, even after prompt restoration of blood flow, a substantial proportion of patients with myocardial infarction (mi) experience extensive necrosis. the application of hypothermia in patients with acute mi focuses on the reducing energy consumption at cardiac level, a factor consistently linked to diminished infarction size in animal study. however, in a recent meta-analysis of randomized trials comparing different strategies for therapeutic hypothermia adjunctive to percutaneous coronary intervention (pci) versus standard of care in patients with acute mi, faille to demonstrate clear benefit. it is important to note, however, these randomized trials were underpowered and as a results, they were unable to draw firm conclusions regarding the impact of therapeutic hypothermia. therefore, this study aimed to investigate the impact of therapeutic hypothermia on clinical outcomes in patients who underwent primary pci for acute mi after ohca.

Eligibility criteria:
inclusion criteria: * out-of-hospital cardiac arrest event exclusion criteria: * arrest of non-cardiac origin * age \< 18 years * did not received primary pci * hypothermia before cag * obey mental status

Keywords: out-of-hospital cardiac arrest acute myocardial infarction hypothermia
shenfu injection for postoperative delirium (sfi for pod)

Conditions: Postoperative Delirium

Summary: surgery or trauma may cause serious problem to patients, especially for senile ones, like postoperative delirium or more postoperative complications. here, we conduct a investigation of sfi for preventing the happening of pod or postoperative complications.

sfi(shenfu injection), a historical medical herbal medicine of traditional chinese, which may produced much benefit to clinical patients with furtigue after major surgery, because it was a comment sense to think of energy loss if they experience surgical damage. here, we administrated intravenously sfi into senile patients, who receiving hip fracture surgery, to avoid bad results or serious postoperative outcomes, in case of enhancing recovery after surgery.

Eligibility criteria:
inclusion criteria: * hip fracture surgery under epidural anesthesia exclusion criteria: * severe dementia, hearing/vision impairment, coma, etc., unable to communicate; * patients with end-stage diseases such as tumor; * 3 months after myocardial infarction, cerebral infarction; * severe heart, liver and renal dysfunction.
postmarket study to evaluate biovance® in diabetic foot ulcers

Conditions: Diabetic Foot Ulcers

Summary: the purpose of this study is to compare the wound closure outcomes of subjects receiving diabetic foot ulcer treatment with and without the use of biovance®.


Eligibility criteria:
inclusion criteria: * the subject has: 1. been diagnosed with diabetes mellitus (insulin or non-insulin dependent) and peripheral neuropathy (loss of protective sensation) in affected foot 2. a hba1c of less than 10% assessed within last 12 weeks 3. a full-thickness diabetic neuropathic foot ulcer that is free from tunnels/sinus tracks, necrotic tissue, exposed bone and/or tendon, and osteomyelitis post debridement (wagner 1 or 2; appendix i) 4. one (target) diabetic neuropathic foot ulcer of less than 12 months duration that has an area that measures ≥ 1.5 and ≤ 10 cm2 post debridement (max length x max width) at screening that is on any surface and part of the foot (fore-, mid- or hind-foot) with an etiology related to loss of protective sensation in that foot. 5. a target ulcer that closed \<30% during the 2 week run-in period (2 weeks management with soc following signature of informed consent prior to potential randomization) 6. sufficient arterial supply to affected foot tested within the past 60 days exclusion criteria: * the subject has: 1. ulcers of non-diabetic etiology on the study foot 2. a target ulcer clinically infected or has underlying osteomyelitis at time of study treatment initiation 3. clinical evidence of gangrene on any part of the affected foot 4. a target ulcer with exposed bone or tendon 5. any malignancy or a neoplasm at the target ulcer site 6. active charcot foot or charcot foot that is unable to be offloaded (stable, non-active charcot deformity that is able to be offloaded is acceptable) 7. more than 3 ulcers on the study foot, including the target ulcer, and all other ulcers must be at least 3 cm removed from the target ulcer 8. any significant comorbid disease that may interfere with wound healing 9. received chemotherapy, radiotherapy, immunosuppressant or corticosteroid (greater than 10 mg prednisone-equivalent per day) within the past 30 days. 10. had the diabetic foot ulcer treated with an experimental drug/biologic/device, or a live-cell therapy (experimental or marketed), or active moist wound healing therapy within 30 days of randomization day
study to estimate the disease burden of acute rotavirus gastroenteritis in children < 5 years in united arab emirates

Conditions: Rotaviral Gastroenteritis

Summary: the purpose of this study is to estimate the disease burden and epidemiology of rotavirus gastroenteritis in children less than 5 years of age, in united arab emirates. acute gastroenteritis cases will be identified from acute gastroenteritis hospitalisation log book and stool samples will be collected from all suspected and confirmed acute gastroenteritis cases.


Eligibility criteria:
inclusion criteria: * a male or female \< 5 years of age at the time of admission to the study hospital for acute gastroenteritis. * written informed consent obtained from the parent or guardian of the subject. exclusion criteria: * the diagnosis for treatment at the study site does not include acute gastroenteritis. * the onset of acute gastroenteritis after admission to the hospital i.e. 48 hours after hospital admission.

Keywords: children gastroenteritis rotavirus